Anaesthesia for Mechanical Thrombectomy

• Conditions: Stroke, Ischemic; Anesthesia

• Registration Number: NCT04804085
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief Summary

Title: Conduct of anaesthesia during acute ischaemic stroke: a retrospective case series of patients undergoing mechanical thrombectomy.

Design: This study will be a retrospective consecutive observational case series

Detailed Description

The Aim of this study is to describe the baseline characteristics, procedural and post-operative clinical characteristics of anaesthetic care delivered to consecutive adult patients who underwent mechanical thrombectomy as part of their routine clinical care between 01/01/2016 and 01/10/2020 at Nottingham University Hospitals NHS Trust (sample size approximately 250).

Study Timeline

• Study First Submitted: 2020-11-09
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-18
• Last Update Posted: 2021-03-18
• Study Start: 2021-06-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Age ≥ 18 years old
• Undergone mechanical thrombectomy for the management of acute ischaemia stroke between 01/01/2016-01/10/2020 at Nottingham University Hospitals NHS Trust.

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Exclusion Criteria

• No pre-specified exclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluating the number of patients requiring mechanical thrombectomy	Through study completion, up to 9 months	This retrospective study will identify the anaesthetic care delivered to a group of patients undergoing mechanical thrombectomy for the management of acute ischaemic stroke. The data collected will be from all patients that received this treatment between 01/01/2016 and 01/10/2020 at Nottingham University Hospitals NHS Trust. This data written up and of interest both to our organisation and to comparable neuroscience centres in the UK and internationally.; Outcomes that will be measured in this clinical case study are highlighted below.

Secondary Outcome Measures

Name	Time	Method
Intra - procedural observations: Measuring time spent with systolic blood pressure (mmHg) <10% of presenting BP (minutes)	Through study completion, up to 9 months
Background information: Age (>/= 18 years of age)	Through study completion, up to 9 months
Background information: Gender (male or female)	Through study completion, up to 9 months	Physiological gender
Background information: The degree of disability/dependence after a stroke will be measured using the presenting modified Rankin Score	Through study completion, up to 9 months	0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.
Background information: Presenting blood pressure (systolic and diastolic)	Through study completion, up to 9 months
Background information: Presenting heart rate (beats per minute)	Through study completion, up to 9 months
Background information: The fitness of the patient will be measured using the American Society of Anaesthetists Classification	Through study completion, up to 9 months	ASA I A normal healthy patient Healthy ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes
Background information: Height of the patient (m)	Through study completion, up to 9 months	BMI = Weight / (height x height)
Background information: Weight of the patient (kg)	Through study completion, up to 9 months	BMI = Weight / (height x height)
Background information: Measuring the distance from referring hospital (miles)	Through study completion, up to 9 months	Hospitals included: Kings Mill Hospital, Royal Derby Hospital, Leicester, Lincoln, Boston, Burton
The patient's stroke classification will be measured using National Institute for Health Stroke Scale	Through study completion, up to 9 months	1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Mode of anaesthesia	Through study completion, up to 9 months	Awake / Sedated / Converted on-table to General Anaesthetic / GA.
To identify the anaesthetic agents used	Through study completion, up to 9 months	Propofol / Alfentanil / Remifentanil / Fentanyl / Midazolam
The level of the anaesthetist (registrar / consultant)	Through study completion, up to 9 months
Intra - procedural observations: Quantifying any episodes of hypoxia (SpO2 <94%)	Through study completion, up to 9 months
Intra-procedural interventions: Identifying if the patient required vasopressors	Through study completion, up to 9 months	None / metaraminol / ephedrine / noradrenaline
Measuring the response of treatment using the post-procedural Thrombolysis in Cerebral Infarction scale	Through study completion, up to 9 months	Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualised Grade 2B: complete filling of all of the expected vascular territory is visualised but the filling is slower than normal Grade 3: complete perfusion
To identify the level of care required immediately post procedure (Level 0,1,2,3)	Through study completion, up to 9 months
Identify the duration of Intensive Care stays (days)	Through study completion, up to 9 months
Identify the duration of stay in hospital (days)	Through study completion, up to 9 months	Whether in NUH or otherwise
To measure the long term outcome: National Institute for Health Stroke Scale at 24 hours post-procedure	Through study completion, up to 9 months	1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
To measure the long term outcome: Modified Rankin Score at 90 days	Through study completion, up to 9 months	0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.
To measure the long term outcome: Mortality at 90 days (survived / deceased)	Through study completion, up to 9 months
To measure the long term outcome: Discharge destination (home / institution)	Through study completion, up to 9 months